Delivery system for coated active components as part of an edible composition

ABSTRACT

A delivery system for inclusion in an edible composition is formulated to have at least one active component with an encapsulating material for delivering the active component when the active component is included in an edible composition and the edible composition is consumed.

BACKGROUND OF THE INVENTION

1. Field of the Invention

A delivery system for inclusion in an edible composition is formulatedto have at least one active component with an encapsulating material fordelivering the active component at a desired release profile when theedible composition is consumed.

2. Description of the Background

High intensity sweeteners generally have a sweetening intensity greaterthan sugar (sucrose) and a caloric value lower than that of sugar atequivalent sweetness levels. In some situations, it is especiallydesirable to control the release of high intensity sweeteners incompositions since the high sweetness levels can easily overwhelm theconsumer. Moreover, the controlled release of the sweetener providesdesirable masking of unpleasant tasting materials and may help bring outflavor characteristics of other ingredients. Because each high intensitysweetener is chemically and physically distinct, each is a challenge touse in an edible composition and each exhibits one or more shortcomings,which may be moderated by encapsulation.

For example, many high intensity sweeteners lose their sweetnessintensity rapidly when used in edible compositions such as chewing gumsand confections with certain flavors. Encapsulation can modulate andprolong release to provide a more desirable taste profile. Some highintensity sweeteners such as saccharin, stevioside, acesulfame-K,glycyrrhizin, and thaumatin have an associated bitter taste or off-note.Certain high intensity sweeteners are also unstable in the presence ofcertain chemicals including aldehydes and ketones, and sensitive toexposure to environmental conditions including moisture. Solid sucraloseis known to turn dark during prolonged storage and/or upon exposure toheat and ambient air. Encapsulation can be used to isolate unstablecompounds to prevent degradation and prolong shelf life.

Typically, the taste profile of a high intensity sweetener can bedescribed as a rapid burst of sweetness. Usually, high intensitysweeteners reach their peak sweet taste rapidly, with the intensity ofsweet taste rapidly declining soon thereafter. The initial rapid burstcan be unpleasant to many consumers as the strong sweet taste tends tooverpower the other flavors that may be present in the ediblecomposition. The relatively rapid loss of sweetness can also result in abitter aftertaste. For this reason, it may be desirable to encapsulatehigh intensity sweeteners with an encapsulating material in order tomodulate and prolong the release and to chemically stabilize and enhancethe overall taste profile.

SUMMARY OF THE INVENTION

The present invention is a significant advance in the art by providing adelivery system that provides controlled and/or delayed release of oneor more active agents.

The present invention provides a new approach to the controlled releaseof an active component in edible compositions such as, for example,chewing gum and confectionery compositions. The active component(s) andmaterials used to encapsulate the same provide a delivery system(s) thatenables exceptional control of the release of the active component overa wide range of delivery systems and takes into account the use of arange of encapsulating materials and additives that may be used toformulate the delivery system. The encapsulated active components arepreserved until release is desirable and therefore protected againstmoisture, reactive compounds, pH changes and the like. When the activecomponent is a sweetener, the delivery system is tailored to thesweetener to provide consistent sustained release, thus extending thetime the sweetener is released to provide an edible composition whichprovides a long lasting desirable taste profile, increased salivationand overall enjoyment of the taste imparted therefrom without thedisadvantage of prior art systems in which the sweetener may be releasedat less or more than a desirable profile.

The present invention, for example, enables the formulation of asuitable target delivery system by focusing on one or more variables(i.e., tensile strength and/orhydrophobicity) and therefore taking intoaccount all components of the delivery system including encapsulatingmaterials and any additives that may be desirably added to theformulation and enables the delivery system when added to an ediblecomposition to release the active component at a desirable releaseprofile.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a graph showing residual sucralose in chewed bolus fromchewing gums containing free or encapsulated coated sucralose.

DETAILED DESCRIPTION OF THE INVENTION

In one aspect of the present invention, there is provided a deliverysystem for inclusion in an edible composition such as a chewing gumcomposition or confectionery composition comprising at least one activecomponent and at least one encapsulating material.

In a further aspect of the present invention there is provided an ediblecomposition such as a chewing gum composition or a confectionerycomposition comprising at least one edible composition-forming componentand a delivery system comprising at least one active component with anencapsulating material.

In a still further aspect of the invention there is provided a method ofpreparing a target delivery system for an edible composition comprisingcombining at least one active component, at least one encapsulatingmaterial, and optionally at least one additive until a preselectedand/or desired target delivery system based on the criteria describedherein is obtained based on comparison with at least one sample deliverysystem having the same or similar active component and a known releaseprofile of the active component.

There is also provided a method of preparing a target delivery systemfor an edible composition useful for delivering at least one activecomponent at a desired release profile, said method comprising mixingthe at least one active component in an encapsulating material in amanner that provides the target delivery system with the preselectedand/or desired characteristics as described herein.

In addition, a method is provided for preparing an edible compositioncontaining at least one delivery system useful for delivering at leastone active component at a desired release profile by mixing the at leastone active component with an encapsulating material in a manner thatprovides the target delivery system with the preselected and/or desiredcharacteristics as described herein associated with the desired releaserate and/or profile enabling the delivery system to release the at leastone active component from the edible composition at desired releaseprofile, and adding the target delivery system to the ediblecomposition.

There is also provided edible compositions containing the deliverysystem described herein. Although one embodiment of the presentinvention relates to chewing gum compositions, confectionerycompositions and beverages, the present invention can be utilized toproduce a variety of edible compositions including, but not limited to,food products, foodstuffs, nutrient-containing compositions,pharmaceuticals, nutraceuticals, vitamins and other products that may beprepared for consumption by the consumer. As used herein, chewing gumcompositions include bubble gum compositions. Because the deliverysystem may be readily incorporated into an edible composition, theedible compositions which may benefit from and are encompassed by thepresent invention are wide ranging as indicated above.

The term “delivery system” as used herein is meant to encompass the atleast one active component with the at least one encapsulating materialas well as other optional additives used to form the delivery system ashereinafter described. It will be understood that the ediblecompositions of the present invention may contain a plurality ofdelivery systems with each delivery system containing a single ormultiple active components.

The term “encapsulating material” is meant to encompass any one or moreedible water insoluble or soluble materials capable of forming a solidcoating or film as a protective barrier around the active component. Asunderstood from the description provided herein, the encapsulatingmaterial forms a matrix with the at least one active component wherebythe encapsulating material can completely encapsulate at least oneactive component, can partially encapsulate the at least one activecomponent, or can associate with the at least one active componentwhereby the encapsulating material provides controlled and/or delayedrelease of the at least one active component in accordance with thedescription herein.

An ingredient in an edible composition will have a release profile whena consumer consumes the edible composition. In some embodiments, theingredient may be released by mechanical action of chewing, and/or bychemical action or reaction of the ingredient with another ingredient orsaliva or other material in the consumer's mouth. The release profilefor the ingredient is indicative of the availability of the ingredientin the consumer's mouth to interact with receptors (e.g., tastereceptors), mucous membranes, teeth, etc. in the consumer's mouth. Anedible composition may include the same or different release profilesfor different ingredients. In some embodiments, the release profile foronly a finite number (e.g., one or two) ingredients may be of primaryimportance.

The release profile of an ingredient in an edible composition can beinfluenced by many factors such as, for example, rate of chewing,intensity of chewing, the amount of the ingredient, how the form of theingredient added to the edible composition (e.g., encapsulated in adelivery system, unencapsulated, pretreated), the edible composition ismixed or otherwise prepared, when or how the ingredient is added toother ingredients in the edible composition, the ratio of the amount ofthe ingredient to the amount of one or more other ingredients in theedible composition, the ratio of the amount of the ingredient to theamount of one or more other ingredients in a delivery system that isincluded in the edible composition, etc.

In some embodiments, a release profile for an ingredient may be relateto a specific time period. For example, release of an ingredient from adelivery system may increase during a first time period, reach a peak,and then decrease during a second time period. Thus, in someembodiments, a release profile for an ingredient may include one or moretime periods, each of which has an associated release rate (which may ormay not be known or measurable). The time periods may be the same lengthof time or may be different lengths of time. A first time period mayhave a fixed or varied release rate for the ingredient during the firsttime period and an average release rate for the ingredient over thefirst time period. Similarly, a second time period may have a fixed orvaried release rate for the ingredient during the second time period andan average release rate for the ingredient over the second time period.In some embodiments, a release profile for an ingredient in an ediblecomposition may include only one time period or be related to only asingle point in time, both of which typically relate or are relative towhen consumption of the edible composition has started. In otherembodiments, a release profile may relate to two or more time periodsand/or two or more points in time, all of which typically relate or arerelative to when consumption of the edible product has started.

In some embodiments, a release profile may be defined or characterizedby one or more factors or characteristics, even if other or all aspectsof the release profile are not determined, selected, or even known.Thus, in some embodiments, a release profile for an ingredient mayinclude only one characteristic. For example, characteristics mayinclude one or more of the following: release rate of an ingredientduring a time period, a specific time period during which a minimum,average, or predominant amount of an ingredient is released duringconsumption of an edible composition that includes the ingredient (evenif some of the ingredient is released before or after the specific timeperiod and even if the release rate during the time period is notspecified or varies), a specific time after which a minimum, average, orpredominant amount if an ingredient is released during consumption of anedible composition that includes the ingredient (even if some of theingredient is released before the specific time and even if the releaserates are or are not specified), etc.

In some embodiments, managing a release profile for one or moreingredients may include changing or otherwise managing the starting andending times for the time periods, changing or otherwise managing thelengths of the time periods, and/or changing or otherwise managing therelease rates during the time periods. For example, managing a releaseprofile may include changing or managing a release rate during a timeperiod. An ingredient can be released more quickly or earlier during afirst or second time period by increasing its release rate during thesetime periods. Likewise, the ingredient can be released more slowly or ina more delayed manner during the first or second time periods bydecreasing its release rate during these time periods. As anotherexample, managing a release profile may include shifting the start andend of the time periods in the release profile, but the length of thetime periods may stay the same and the release rates of theingredient(s) during the time periods may stay the same (e.g., therelease of an ingredient may be managed to delay the release of thepredominant amount of the ingredient by one minute, five minutes, tenminutes, thirty minutes, etc.). As a third example, managing a releaseprofile may include shifting the start or end of one or more timeperiods and changing the release rate within the one or more timeperiods.

In some embodiments, causing a delay in a release of an ingredient in anedible composition includes causing a delay in the release oravailability of the predominant of the ingredient after consumption ofthe edible product begins and/or causing release or availability of adesire, predominant, or minimum amount of the ingredient at a certaintime, after a certain time, or during a desired time period afterconsumption of the edible composition begins. In some embodiments, noneof the ingredient will be released or become available before thecertain time or before or after the desired time period. In otherembodiments, some of the ingredient may be released or become availablebefore the certain time and/or before or after the desired time period.

In some embodiments, determining or selecting a desired release profilemay include determining or selecting one or more factors orcharacteristics of the desired release profile, as previously describedabove. The factors or characteristics then serve to define orcharacterize the release profile, even if other or all aspects of therelease profile are not determined or selected. Thus, determining orselecting a release profile for an ingredient can includes situationswhere only one characteristic for the release of the ingredient isdetermined or selected. In some embodiments, characteristic may bedetermined or measured by one or more techniques or methods such as, forexample, chemical and/or mechanical testing and analysis, consumertesting, descriptive or expert taste or chew panel, other in vivo or invitro testing, etc.

The present invention is directed generally to a delivery system asdefined herein for use in edible compositions, which comprises at leastone active component with at least one encapsulating material. Thedelivery system of the present invention is formulated to provideconsistent controlled release of the active component over a preselectedperiod of time, such as an extended period of time. This period of timemay vary depending on the type of product in which the delivery systemis incorporated, the type of encapsulating material, the type of active,other ingredients (e.g. fats) in the product, etc. One of skill in theart, based on the disclosure herein can adjust the delivery system toachieve the desired effect.

An extended period of time as used herein, relates to an increasedrelease of the active ingredient from the delivery system for over agreater period of time than previously described systems and can be atleast 15 minutes, including at least 20 minutes, at least 25 minutes, atleast 30 minutes, as well as all values and ranges there between, forexample, about 25 to 30 minutes, 45 to 60 minutes or more. Furthermore,the delivery system of the present invention also provides a way to notonly deliver active agents over a prolonged period of time but alsomaintain an increased intensity of the active ingredient over theextended period of time. For example, if the active ingredient is aflavor or sweetener then in one aspect of the invention, the amount ofactive agent released can vary during the extended period of time. Forexample, at an early stage of delivery the amount of active componentreleased (based on the total amount present in the delivery system atthat time) can be greater than the amount of active component releasedduring subsequent or later periods (based on the total amount present inthe delivery system at that time).

In one embodiment, the extended period of time results in retaining atleast about 5% of the at least one active component after 30 minutesfrom the start of delivering the active component in the ediblecomposition, such as the start of chewing a chewing gum composition,including at least about 10%, 15%, 20%, 25%, 30%, or more after 30minutes. In another embodiment, the extended period of time results inretaining at least about 10% of the at least one active component after20 minutes from the start of delivering the active component, includingat least about 15%, 20%, 25%, 30%, 40%, 50% or more after 20 minutes. Inanother embodiment, the extended period of time results in retaining atleast about 30% of the at least one active component after 15 minutesfrom the start of delivering the active component, including at leastabout 30%, 40%, 50%, 60%, 70%, 75% or more after 15 minutes.

In another embodiment, using sweetener in chewing gum as an example, theextended period of time results in a perceived sweetness intensityduring at least the entire period of time noted above, e.g., at leastabout 15 minutes, at least about 20 minutes, at least about 30 minutes,etcetera from the start of chewing the chewing gum composition.Moreover, extending the period of time that the sweetener is availableduring chewing may extend the amount of time that flavor is perceived bythe consumer.

The delivery system facilitates the controlled release of the activecomponent in a wide variety of edible compositions including chewing gumcompositions, food products, confectionery compositions, pharmaceuticalcompositions, beverages, foodstuffs, nutrient-containing compositions,vitamins, nutraceuticals and the like.

The delivery system is developed in accordance with the presentinvention may be selected, depending in part on the active component andthe release profile of the desired active component, from a standard ofknown delivery systems containing the active component with a knownrelease profiles. The active components which are part of the deliverysystem may be selected from sweeteners including high intensitysweeteners, acids, flavorants, pharmaceuticals, therapeutic agents,vitamins, minerals, a tooth whitener or cleaner, breath fresheners,cooling agents, warming agent, a sensate, and other materials that wouldbenefit by coating for protection, controlled release and/or for tastemasking. The active components include nicotine useful for the treatmentof addiction to tobacco products and caffeine typically found in coffeeand/or beverages. In one embodiment of the present invention, the activecomponent is a sweetener, for example a high intensity sweetener such asneotame, aspartame, sucralose, acesulfame potassium and others asdescribed herein.

It has been found in accordance with the present invention that adelivery system for delivering an active component can be formulated toensure an effective sustained release of the active component based onthe type and amount of the active component and desired release profile.For example, it may be desirable to affect the release of a highintensity sweetener over a period of 25 to 30 minutes to ensure againsta rapid burst of sweetness which may be offensive to some consumers. Ashorter release time may be desirable for other type of activecomponents such as pharmaceuticals or therapeutic agents, which may beincorporated into the same edible composition by using separate deliverysystems for each active component. In accordance with the presentinvention, delivery systems may be formulated based on a range ofrelease profiles relative to a standard. The standard may comprise aseries of known delivery systems having, for example, a polymerencapsulating material having specific hydrophobicity and/or tensilestrengths over a range. Each of the delivery systems of the standardwill be associated with a particular release profile or ranges ofrelease profiles.

In one embodiment, the present invention includes the incorporation of aplurality of delivery systems to deliver a plurality of separate activecomponents including active components which may be desirably releasedat distinctly different release profiles in order to obtain a desiredrelease profile. The active components can be the same or different.Different delivery systems may use different active components and/ordifferent encapsulating materials.

For example, high intensity sweeteners may desirably be released over anextended period of time (e.g. 20 to 30 minutes) while somepharmaceuticals are desirably released over a significantly shorterperiod of time.

In certain embodiments of the present invention, the delivery system canbe prepared such that the release of at least a portion or all of the atleast one active agent is at specific rates relative to the time ofdelivery. For example, in one embodiment, the delivery system can beprepared such that the release of the at least one active agent isreleased at a rate of 80% over the course of 15 minutes, 90% over thecourse of 20 minutes, and/or a 95% over the course of 30 minutes. Inanother embodiment, the delivery system can be prepared such that theone or more active agents are released at a rate of 25% over the courseof 15 minutes, 50% over the course of 20 minutes and/or 75% over thecourse of 30 minutes. For example, using chewing gum as an example, thesame sweetener can be incorporated into two different delivery systems,one of which provides an early release and second providing a moredelayed release to contribute to longer lasting perceived sweetnessand/or flavor by the consumer.

Hydrophobicity of the Encapsulating Material

In one aspect of the present invention, the release profile of theactive component can be mangaged by formulating the delivery systembased on the hydrophobicity of the encapsulating material, e.g.,polymer. Using highly hydrophobic polymers to form a delivery system,the release of the active component can be delayed during consumption ofan edible product that includes the delivery system. In a similarmanner, using encapsulating material that is less hydrophobic, theactive component can be released earlier or more rapidly.

Hydrophobicity can be quantitated by the relative water-absorptionmeasured according to American Society of Testing Materials in methodnumber ASTM D570-98. Thus, by selecting encapsulating material withrelatively lower water-absorption properties and adding that to themixer, the release of the active component contained in the produceddelivery system can be delayed compared to those encapsulating materialshaving higher water-absorption properties. In certain embodiments, adelivery system with encapsulation material having a water absorption offrom about 50 to 100% (as measured according to ASTM D570-98) can beused. To decrease the relative delivery of the active component or delaythe release of the active component, the encapsulating material can beselected such that the water absorption would be from about 15 to about50% (as measured according to ASTM D570-98). Still further, in otherembodiments, the water absorption properties of the encapsulatingmaterial can be selected to be from 0.0 to about 5% or up to about 15%(as measured according to ASTM D570-98) to create even more delay in therelease of the active component.

In other embodiments, mixtures of two or more delivery systemsformulated with encapsulating material having different water-absorptionproperties can also be used in subsequent incorporation into an ediblecomposition. When combining two or more delivery systems, one can managethe release of the active components such that, for example, some of theactive is released at an earlier stage during consumption of the edibleproduct containing the same and some of the active is released at alater stage during consumption.

Polymers with suitable hydrophobicity which may be used in the contextof the present invention include homo- and co-polymers of, for example,vinyl acetate, vinyl alcohol, ethylene, acrylic acid, methacrylate,methacrylic acid and others. Suitable hydrophobic copolymers include thefollowing non-limiting examples, vinyl acetate/vinyl alcohol copolymer,ethylene/vinyl alcohol copolymer, ethylene/acrylic acid copolymer,ethylene/methacrylate copolymer, ethylene/methacrylic acid copolymer.

In some embodiments, the hydrophobic encapsulating material may bepresent in amounts of from about 0.2% to 10% by weight based on thetotal weight of the edible composition, including 0.3, 0.5, 0.7, 0.9,1.0, 1.25, 1.4, 1.7, 1.9, 2.2, 2.45, 2.75, 3.0, 3.5, 4.0, 4.25, 4.8,5.0, 5.5, 6.0, 6.5, 7.0, 7.25, 7.75, 8.0, 8.3, 8.7, 9.0, 9.25, 9.5, 9.8and all values and ranges there between, for example, from 1% to 5% byweight. The amount of the encapsulating material will, of course, dependin part on the amount of the active component used. The amount of theencapsulating material with respect to the weight of the deliverysystem, is from about 30% to 99%, including 35, 40, 45, 50, 55, 60, 65,70, 75, 80, 85, 95, 97 and all values and ranges there between, forexample, from about 60% to 90% by weight.

In formulating the delivery system based on the selection criteria ofhydrophobicity of the encapsulating material, the active component canbe entirely encapsulated within the encapsulating material orincompletely encapsulated within the encapsulating material provided theresulting delivery system meets the criteria set forth hereinabove. Theincomplete encapsulation can be accomplished by modifying and/oradjusting the manufacturing process to get partial coverage of theactive component. In some embodiments, the encapsulation material mayform a matrix with the active component.

For example, if ethylene-vinyl acetate is the encapsulating material,the degree of hydrophobicity can be controlled by adjusting the ratio ofethylene and vinyl acetate in the copolymer. The higher theethylene:vinylacetate ratio, the slower the release of the activecomponent. Using vinylacetate/ethylene copolymer as an example, theratio of the vinylacetate/ethylene in the copolymer can be from about 1to about 60%, including ratios of 2.5, 5, 7.5, 9, 12, 18, 23, 25, 28,30, 35, 42, 47, 52, 55, 58.5% and all values and ranges there between.

One embodiment of the present invention is a method of selecting atarget delivery system containing an active component for an ediblecomposition based on the hydrophobicity of the encapsulating material.The method generally includes preparing a targeted delivery systemcontaining an active component, an encapsulating material and optionaladditives, with the encapsulating material having a pre-selectedhydrophobicity. The hydrophobicity of the encapsulating materialemployed in the targeted delivery system is pre-selected to provide adesirable release profile of the active component. This selection of theencapsulating material is based on the hydrophobicity of sample deliverysystems having the same or similar active component and known releaseprofiles of the active component.

In another embodiment of the invention, the method comprises (a)obtaining a plurality of sample delivery systems comprising an activecomponent, at least one encapsulating material, and optional additives,wherein each of the delivery systems is prepared with differentencapsulating materials having different hydrophobicities; (b) testingthe sample delivery systems to determine the respective release profilesof the active component; and (c) formulating a target delivery systemcontaining the same active component with a hydrophobic encapsulatingmaterial corresponding to a desired release profile of the activecomponent based on the obtained sample delivery systems.

The method of selecting at least one delivery system suitable forincorporation into an edible composition can begin by determining adesired release profile for an active component (i.e. a first activecomponent). The determination of the desired release profile may be fromknown literature or technical references or by in vitro or in vivotesting. Once the desired release profile is determined, the desiredhydrophobicity of the encapsulating material can be determined (i.e. afirst hydrophobic encapsulating material) for a delivery system (i.e.first delivery system) that can release the first active component atthe desired release. Once the delivery system is obtained which candeliver the active component as required it is then selected foreventual inclusion in an edible composition.

The method described above may then be repeated for a second activecomponent and for additional active components as described via thedetermination and selection of a suitable delivery system.

The edible compositions may contain two or more types of deliverysystems, each containing the same or different active components, theselection of delivery systems based on the hydrophobicity of theencapsulating material and/or the tensile strength of the deliverysystems as described in the following. Additionally or alternatively,one or more delivery systems may be incorporated into an ediblecomposition with free (non-encapsulated) active components, such asaspartame, sucralose, neotame and ace K sweeteners.

Tensile Strength of the Delivery System

In a further embodiment, the selection of a delivery system, in additionto being based on the hydrophobic character of the encapsulatingmaterial, can be selected based on the manipulation and selection of thetensile strength of the encapsulating material to provide a delayedand/or controlled release of the active component. Thus, the controlledand/or delayed release of the active component can be controlled byselecting a predetermined tensile strength and a predeterminedhydrophobicity of the encapsulating material.

As used herein, the term “tensile strength” means the maximum stress amaterial subjected to a stretching load can withstand without tearing. Astandard method for measuring tensile strength of a given substance isdefined by the American Society of Testing Materials in method numberASTM-D638.

The predetermined tensile strength is determined based, in part, on theactive component and the desired release time of the same. Thepredetermined tensile strength may be selected from a standard comprisedof one or more delivery systems with each standard delivery systemhaving a known release profile of the desired active component. Thedelivery system of the present invention further provides the activecomponent with a protective barrier against moisture and otherconditions such as pH changes, reactive compounds and the like, thepresence of which can undesirably degrade the active component.

It will be understood that a plurality of delivery systems may beprepared in this manner each containing a different active component byutilizing a comparison with standard delivery systems containing suchdifferent active components.

By maintaining the tensile strength of the delivery system within apreselected desirable range, the active component is released from thecomposition in a highly controlled and consistent manner. By focusing onthe tensile strength of the delivery system, the process for selectingand formulating suitable delivery systems is enhanced in a manner whicheffectively reduces the need for trial and error experimentationtypically necessary in prior art systems.

The desired tensile strength of the delivery system can be readilydetermined within a desired range. In one embodiment of the presentinvention, the tensile strength of the delivery system is at least 6,500psi, including 7500, 10,000, 20,000, 30,000, 40,000, 50,000, 60,000,70,000, 80,000, 90,000, 100,000, 125,000, 135,000, 150,000, 165,000,175,000, 180,000, 195,000, 200,000 and all ranges and subranges therebetween, for example a tensile strength range of 6,500 to 200,000 psi.The formulation of a delivery system with a desirable tensile strengthcan be made from a variety of encapsulating materials and at least oneadditive which hereinafter are referred to as “at least one tensilestrength modifying agent or modifier.” The at least one additive may beused to formulate the delivery system by modifying the tensile strengthof the delivery system, including tensile strength-lowering materialssuch as fats, emulsifiers, plasticizers (softeners), waxes, lowmolecular weight polymers, and the like, in addition to tensile strengthincreasing materials such as high molecular weight polymers. Inaddition, the tensile strength of the delivery system can also be finetuned by combining different tensile strength modifiers to form thedelivery system. For example, the tensile strength of high molecularweight polymers such as polyvinyl acetate may be reduced when tensilestrength lowering agents such as fats and/or oils are added.

In one embodiment of the present invention, at least one tensilestrength modifying agent is present in the delivery system in an amountsufficient such that the release of the one or more active agents,wholly or partly, contained in the delivery system is released at a rateof 80% over the course of 15 minutes, 90% over the course of 20 minutes,and/or 95% over the course of 30 minutes. In another embodiment, the atleast one tensile strength modifying agent is present in the deliverysystem in an amount sufficient such that the one or more active agentsare released at a rate of 25% over the course of 15 minutes, 50% overthe course of 20 minutes and/or 75% over the course of 30 minutes.

In another embodiment of the present invention, the at least one tensilestrength modifying agent is present in the delivery system in an amountsufficient such that the tensile strength of the delivery system is atleast about 6,500 psi, including 7500, 10,000, 20,000, 30,000, 40,000,50,000, 60,000, 70,000, 80,000, 90,000, 100,000, 125,000, 135,000,150,000, 165,000, 175,000, 180,000, 195,000, 200,000 and all ranges andsubranges there between, for example a tensile strength range of 6,500to 200,000 psi.

Examples of tensile strength modifiers or modifying agents include, butare not limited to, fats (e.g., hydrogenated or non-hydrogenatedvegetable oils, animal fats), waxes (e.g., microcrystalline wax, beeswax), plasticizers/emulsifiers (e.g., mineral oil, fatty acids, mono-and diglycerides, triacetin, glycerin, acetylated monoglycerides,glycerol rosin monostearate esters), low and high molecular weightpolymers (e.g., polypropylene glycol, polyethylene glycol,polyisobutylene, polyethylene, polyvinylacetate) and the like, fillerlike talc, dicalcium phosphate, calcium carbonate, silica, andcombinations thereof. Plasticizers may also be referred to as softeners.

Thus, by employing tensile strength modifiers, the overall tensilestrength of the delivery system can be adjusted or altered in such a waythat a preselected tensile strength is obtained for the correspondingdesired release profile of the active component from an ediblecomposition based on a comparison with a standard.

The delivery systems of the present invention produce controlled releaseof the active components as desired through the use of a preselectedtensile strength when matched with a desirable release profile selectedaccording to the type of the active components used, the encapsulatingmaterial used, the additives incorporated, the desired rate of releaseof the active component, and the like. The encapsulating materials usedfor the delivery systems are generally selected from edible waterinsoluble materials capable of formning a strong matrix, solid coatingor film as a protective barrier around the active component. Theencapsulating material is chosen in a manner consistent with the tensilestrength of the delivery system which can be at least 6,500 psi,including 7500, 10,000, 20,000, 30,000, 40,000, 50,000, 60,000, 70,000,80,000, 90,000, 100,000, 125,000, 135,000, 150,000, 165,000, 175,000,180,000, 195,000, 200,000 and all ranges and subranges there between,for example a tensile strength range of 6,500 to 200,000 psi. Suchencapsulating materials may be selected from polyvinyl acetate,polyethylene, crosslinked polyvinyl pyrrolidone, polymethylmethacrylate,polylactic acid, polyhydroxyalkanoates, ethylcellulose, polyvinylacetatephthalate, polyethylene glycol esters,methacrylicacid-co-methylmethacrylate, and the like, and combinationsthereof.

The encapsulating material, based on the selection of hydrophobicity ofthe encapsulating material and the tensile strength of the deliverysystem, may be present in amounts of from about 0.2% to 30% by weightbased on the total weight of the edible composition, including 0.3, 0.5,0.7, 0.9, 1.0, 1.25, 1.4, 1.7, 1.9, 2.2, 2.45, 2.75, 3.0, 3.5, 4.0,4.25, 4.8, 5.0, 5.5, 6.0, 6.5, 7.0, 7.25, 7.75, 8.0, 8.3, 8.7, 9.0,9.25, 9.5, 9.8, 12, 14, 15, 18, 21, 24, 26, 28 and all values and rangesthere between, for example, from 1% to 5% by weight. The amount of theencapsulating material will, of course, depend in part on the amount ofthe active component present in the delivery system. The amount of theencapsulating material with respect to the weight of the deliverysystem, is from about 30% to 99%, including 35, 40, 45, 50, 55, 60, 65,70, 75, 80, 85, 95, 97 and all values and ranges there between, forexample, from about 60% to 90% by weight.

The tensile strength of the delivery system may be selected fromrelatively high tensile strengths when a relatively slower or delayrelease is desired and relatively lower tensile strengths when a fasteror quicker release is desired. Thus, when employing a tensile strengthof 50,000 for a delivery system, the release of the active component,will generally be delayed in comparison to the release of the activecomponent in a delivery system having a tensile strength of 10,000 psiregardless of the type of encapsulating material (e.g. polyvinylacetate) chosen as long as the hydrophobicity of the encapsulations iskept consistently similar or identical.

In one embodiment of the present invention, the encapsulating materialis polyvinyl acetate. A representative example of a polyvinyl acetateproduct suitable for use as an encapsulating material in the presentinvention is Vinnapas® B100 sold by Wacker Polymer Systems of Adrian,Mich. A delivery system utilizing polyvinyl acetate may be prepared bymelting a sufficient amount of polyvinyl acetate at a temperature ofabout 65° to 120° C. for a short period of time, e.g., 5 minutes. Themelt temperature will depend on the type and tensile strength of thepolyvinyl acetate encapsulating material where higher tensile strengthmaterials will generally melt at higher temperatures. Once theencapsulating material is melted, a suitable amount of the activecomponent (e.g., high intensity sweetener such as aspartame) is addedand blended into the molten mass thoroughly for an additional shortperiod of mixing. The resulting mixture is a semi-solid mass, which isthen cooled (e.g., at 0° C.) to obtain a solid, and then ground to aU.S. Standard sieve size of from about 30 to 200 (900 to 75 microns).The tensile strength of the resulting delivery system can readily betested according to ASTM-D638 after molding the encapsulations inrequired size and shape.

The selection of a suitable encapsulating material will also depend inpart on the type and amount of the active component and the presence ofother additives or ingredients. Plasticizers or softeners as well asfats and oils, for example, act as “tensile strength modifying agents”and may be incorporated into the delivery system and particularly intothe encapsulating material to modify the tensile strength of theresulting delivery system. The above mentioned additives may be added tothe encapsulating material during the molten state. The amount ofadditives used in the delivery system of the present invention will ofcourse vary according to the desired tensile strength can range up to40% by weight based on the total weight of the delivery system.

In formulating the delivery system to have a predetermined tensilestrength and a preselected hydrophobic encapsulating material, theactive component can be entirely encapsulated within the encapsulatingmaterial or incompletely encapsulated within the encapsulating materialprovided the resulting tensile strength of the delivery system meets thecriteria set forth hereinabove. The incomplete encapsulation can beaccomplished by modifying and/or adjusting the manufacturing process toget partial coverage of the active component.

The presence of fats and oils as an additive has been found to have twoeffects on the delivery system. The first effect is observed at lowerconcentrations, i.e. up to 5% by weight, including up to 4.7, up to 4.5,up to 4.25, up to 4.0, up to 3.5, up to 3.0, up to 2.5, up to 2.25, upto 2.0, up to 1.75, up to 1.5, up to 1.0 and all values and rangestherebetween, wherein the fats and/or oils either maintain or increasethe tensile strength of the delivery system. At higher concentrations(i.e., typically above 5% by weight), the fats and/or oils tend toreduce the tensile strength of the delivery system. Even with suchunusual or non-linear effects on the tensile strength of the deliverysystem, a suitable delivery system with the desired release of theactive component may be readily formulated in accordance with thepresent invention because the targeted delivery system is prepared basedon sample delivery systems having known release profiles for the activecomponent.

In a one embodiment of the present invention, there is provided a methodof selecting a target delivery system containing an active component foran edible composition based on the hydrophobicity of the encapsulatingmaterial and the tensile strength of the delivery system. The methodgenerally includes preparing a targeted delivery system containing anactive component, an encapsulating material and optional additives, withthe encapsulating material having a pre-selected hydrophobicity and thetargeted delivery system having a pre-selected tensile strength. Thetensile strength of the targeted delivery system and the hydrophobicityof the encapsulating material is pre-selected to provide a desirablerelease profile of the active component. This selection of the tensilestrength is based on the tensile strengths of sample delivery systemshaving the same or similar active component and known release profilesof the active component. Likewise, the selection of the encapsulatingmaterial is based on the hydrophobicity of sample delivery systemshaving the same or similar active component and known release profilesof the active component.

In a another embodiment of the invention, the method comprises the stepsof (a) obtaining a plurality of sample delivery systems comprising anactive component, at least one encapsulating material, and optionaladditives, wherein each of the delivery systems has a different tensilestrength and encapsulating material having a different hydrophobicity;(b) testing the sample delivery systems to determine the respectiverelease profiles of the active component; and (c) formulating a targetdelivery system containing the same active component with a tensilestrength and hydrophobicity of the encapsulating material correspondingto a desired release profile of the active component based on theobtained sample delivery systems.

The method of selecting at least one delivery system suitable forincorporation into an edible composition can begin by determining adesired release profile for an active component (i.e. a first activecomponent). The determination of the desired release profile may be fromknown literature or technical references or by in vitro or in vivotesting. Once the desired release profile is determined, it is typicalto determine the desired tensile strength and the desired hydrophobicityof the encapsulating material for a delivery system that can release thefirst active component at the desired release. Once the delivery systemis obtained which can deliver the active component as required it isthen selected for eventual inclusion in an edible composition.

The method described above may then be repeated for a second activecomponent and for additional active components as described via thedetermination and selection of a suitable delivery system.

One of the desirable properties of solid dosage forms, such as an ediblecomposition or a chewing gum, is that release of the active component,such as a sweetener, can be uniform throughout the chew time. Forexample, with free (non-encapsulated) sweeteners, the release rate isquick and the taste of gum is not desirable at the late chewing time.With delivery systems having a high tensile strength, the release rateis delayed so that the sweetener releases late in chewing time. Tobalance early and late release rates of the active components, forexample, an edible composition can be manufactured so that it contains amixture of free actives with delivery systems having high tensilestrength and/or hydrophobicity and/or combinations of two or moredelivery systems having different tensile strength and/orhydrophobicities designed such that the active component is released atdifferent rates.

For example, an edible composition such as a chewing gum composition cancontain a sweetener, e.g., aspartame, in both free form(non-encapsulated) and in one or more delivery systems having a tensilestrength of at least 6,500 psi, with increasing tensile strengthcreating a more delayed release profile of the sweetener. Alternativelyor in combination with the tensile strength, the delivery system canhave a water retention of at least 50%.

Another example of an edible composition can incorporate two or evenseveral delivery systems whereby one delivery system is prepared to havea tensile strength of about 6,500 psi and a second delivery system tohave a tensile strength of about 50,000 psi. Non-encapsulated (free)active can also be included to provide an initial rapid release of theactive. In addition to or as an alternative, the edible composition canbe prepared such that the first delivery system has water retentionvalue of about 5 to 15% and the second delivery system has a waterretention value of 50 to 100%.

In this manner, the selection of a delivery system can be based on themanipulation and selection of the proportion of the amount of the atleast one non-encapsulated active component to the amount of at leastone encapsulated material having a desired parameter and/orcharacteristic to provide a delayed and/or controlled release of theactive component. Such that the composition will release the active atboth an early stage of 0 to 10 minutes or later stages 15-30 minutes aswell as combinations of these times, including all values and subrangestherebetween.

For typical edible compositions including chewing gum compositions,confectionery compositions and beverage compositions, thenon-encapsulated and non-encapsulated active components (e.g.,sweeteners) may be present in amounts of from about 0.1% to 6% by weightbased on the total weight of the edible composition, including 0.5, 1,2, 3, 4, 5% by weight and all values and subranges there between, forexample, 0.5% to 3% by weight.

Coating the Active Component

In some instances, some of the active components in the delivery systemmay be miscible with the encapsulating material. For example,polyvinylacetate is one type of encapsulating material that can be usedin the present invention. Some components, such as flavor which areshort or medium chain esters, may interact with the polyvinylacetate(PVAc) and thereby reduce the effectiveness of the controlled and/ordelayed release profile of the active component.

Therefore, one embodiment of the present invention, by itself orcombined with the other embodiments described herein, is coating theactive component with a “coating material” that is not miscible or atleast less miscible relative to its miscibility with the encapsulatingmaterial. The active component can be coated with the coating materialprior to or concurrently with its encapsulation with the encapsulatingmaterial.

The coating material according to the present invention can reduce themiscibility of the active component with the encapsulating material atleast 5%, preferably at least 25%, more preferably at least 50%,including, 10, 15, 20, 30, 40, 60, 70, 75, 80, 85, 90, 95% or morerelative to the miscibility of the active component which is not coatedby the coating material.

In one embodiment, the material used to coat the active component is awater soluble and/or hydrophilic material. Non-limiting examples ofsuitable coating materials include, gum Arabic, cellulose, modifiedcellulose, gelatin, polyols (eg., sorbitol, maltitol), cyclodextrin,zein, polyvinyl alcohol, polymethylmethacrylate, and polyurethane.Mixtures of various coating materials may also be used.

The coating thickness will vary depending on starting particle size andshape of the active material as well as the desired weight percentcoating level. In accordance with the present invention, the coatingthickness is preferably from about 1 to about 200 microns, including 10,20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170,180 and 190 microns and all values and ranges there between, forexample, the thickness of coating material can be from about 10 to about50 microns and 20 to 54% by weight.

In addition to providing a barrier stability that can reduce and/oreliminate the miscibility of the active component, the coating materialused in the present invention may also have good film forming propertieswhich facilitates the formation of a barrier between the activecomponent and the encapsulating material. Film forming properties asused herein means that the coating material, after dissolution in atleast one solvent (such as, for example, water and/or organic solvents),leaves a film on the active component to which it is applied, forexample, once the at least one solvent evaporates, absorbs and/ordissipates on the active component. Furthermore, when the coatingmaterial is used in the preparation of edible compositions, such aschewing gum, one of ordinary skill in the art recognizes that thecoating material should be chosen based on its taste, shelf life,stickiness, resistance to microbial growth, and other common criteriafor selecting ingredients for consumption.

The active component can be coated with the coating material by applyingthe coating material to the active component using a pan, spray, batch,and/or continuous processes typically used to coat materials. In oneembodiment, the coating material is dissolved or dispersed in a solventto facilitate coating on the active component. The coating material canbe delivered using conventional methods of coating substrates. In apreferred method of coating, a fluidized bed technique is employed whichis described, for example, in U.S. Pat. No. 3,196,827, the relevantcontents of which are incorporated herein by reference.

In a further embodiment, by coating the active component andencapsulating the active component according to the description providedherein, a longer shelf life of the edible compositions can be attained.As used herein, shelf life is an indicia of the stability of thecomponents of the edible compositions containing the active component.Using flavorants and/or sweeteners for illustration, this increase inshelf life can be assessed by determining the perceived flavor and/orsweetness of the flavorant and/or sweetener contained in thecomposition. According to the present invention, when using a coatingmaterial to coat the active component a 5% increase in shelf liferelative to a similar product in which the active component has not beencoated with the barrier material can be achieved, including 10, 20, 30,40, 50, 60, 70, 80, 90, 100% or more, as well as all values and rangesthere between, increased shelf life. In another embodiment, the longershelf life can be correlated to the time of storage after manufacture,for example at 10 weeks the shelf life the composition containing thecoated active component will demonstrate a 50%, 75%, 80%, or 90%improvement relative to a similar composition but not containing anactive component coated with a coating material according to theinvention described herein. In a further example, at 24 weeks ofstorage, the coated active component will show an 80 to 90% improvementrelative to a similar composition but not containing the activecomponent coated with a coating material as according to the inventiondescribed herein.

Polymer Matrix

In another embodiment of the present invention, the active component canencapsulated into the delivery system used to provide controlled and/ordelayed release by forming a polymer matrix. In the formation of apolymer matrix, the encapsulating material is mixed with the activecomponent in an amount sufficient to encapsulate the active componentand thereafter compressed into a tablet at or about ambient temperature.Heating up to but not exceeding the softening point of the encapsulatingmaterial further form the compressed tablet. The formation of the tabletwith compression and under relatively low heat facilitates theencapsulation of active ingredients that are susceptible to heatdegradation or relatively unstable when heat is applied.

A compression force from about 7 to about 28 KN (about 1573-6300 lbf)can be used, including 6, 8, 10, 12, 14, 15, 16, 18, 20, 22, 24, 26, 27,28.5 and all values and subranges there between. In one embodiment, thepolymer matrix encapsulating the active component can be made using aPiccola Model D-8 laboratory rotary tablet press.

In certain embodiments, the polymer matrix formed at or about ambienttemperature can be mixed with other polymer matrices formed in the sameway and/or the other delivery systems described herein. By combiningvarious delivery systems, a profile of release of different or the sameingredients can be controlled, e.g., to have fast release from one and alonger, delayed release from a second.

The polymer encapsulating material used for the preparation of thepolymer matrix is preferably chosen such that it has sufficient tensilestrength, sufficient adhesion properties, be chemically inert, andsufficient hydrophobicity to permit suitable controlled release of theencapsulated active component. Non-limiting examples of polymers whichcan be used to form the polymer matrix include polyvinyl acetate,polyethylene, cross-linked polyvinyl pyrrolidone,polymethylmethacrylate, polylactidacid, polyhydroxyalkanoates,ethylcellulose, polyvinyl acetatephthalate, polyethylene glycol esters,methacrylicacid-co-methylmethacrylate, and the like. Combinations ofpolymers may also be used.

The polymer encapsulating material may be present in amounts of fromabout 0.2% to 10% by weight based on the total weight of the ediblecomposition, including 0.3, 0.5, 0.7, 0.9, 1.0, 1.25, 1.4, 1.7, 1.9,2.2, 2.45, 2.75, 3.0, 3.5, 4.0, 4.25, 4.8, 5.0, 5.5, 6.0, 6.5, 7.0,7.25, 7.75, 8.0, 8.3, 8.7, 9.0, 9.25, 9.5, 9.8 and all values and rangesthere between, for example, from 1% to 5% by weight. The amount of theencapsulating material will, of course, depend in part on the amount ofthe active component which must be encapsulated. The amount of theencapsulating material with respect to the weight of the deliverysystem, is from about 30% to 99%, including 35, 40, 45, 50, 55, 60, 65,70, 75, 80, 85, 95, 97 and all values and ranges there between, forexample, from about 60% to 90% by weight.

The active component can be entirely encapsulated with the encapsulatingmaterial constituting the polymer matrix or incompletely encapsulatedwithin the encapsulating material provided the delivery system meets thepreselected criteria for extended and/or delayed release of the activecomponent. The incomplete encapsulation can be accomplished by modifyingand/or adjusting the manufacturing process to get partial coverage ofthe active component.

The polymer matrix used as a delivery system for active components in asimilar manner as those described hereinabove. Like those deliverysystems the polymer matrix can be prepared to a desired tensile strengthand/or the selection of encapsulating material based on itshydrophobicity to permit the delivery of the active component at acontrolled and/or delayed release profile having the desiredcharacteristics as described hereinabove. As described hereinabove, thetensile strength of the polymer matrix can be modified using tensilestrength modifiers or modifying agents as described hereinabove.

In a preferred embodiment, the tensile strength of the polymer matrixranges from about 4000 to about 300,000 psi after the heating step,including 5000, 10000, 25000, 50,000, 75000, 90,000, 100000, 125000,155000, 180000, 205000, 230000, 255000, 270000, 295000 psi and allvalues and subranges there between.

In a one embodiment of the present invention, there is provided a methodof selecting a target delivery system constituting a polymer matrixcontaining an active component for an edible composition based on thehydrophobicity of the encapsulating material and/or the tensile strengthof the delivery system. The method generally includes preparing apolymer matrix containing an active component, an encapsulating materialand optional additives, with the encapsulating material having apre-selected hydrophobicity and/or a pre-selected tensile strength. Thetensile strength of the polymer matrix and/or the hydrophobicity of theencapsulating material is pre-selected to provide a desirable releaseprofile of the active component. This selection of the tensile strengthis based on the tensile strengths of sample polymer matrices having thesame or similar active component and known release profiles of theactive component. Likewise, the selection of the encapsulating materialis based on the hydrophobicity of sample polymer matrices having thesame or similar active component and known release profiles of theactive component.

In another embodiment of the invention, the method comprises the stepsof (a) obtaining a plurality of sample polymer matrices comprising anactive component, at least one encapsulating material, and optionaladditives, wherein each of the polymer matrices has a different tensilestrength and/or encapsulating material having a differenthydrophobicity; (b) testing the sample polymer matrices to determine therespective release profiles of the active component; and (c) formulatinga target polymer matrix containing the same active component with atensile strength and/or hydrophobicity of the encapsulating materialcorresponding to a desired release profile of the active component basedon the obtained sample polymer matrices.

The method of selecting at least one polymer matrix suitable forincorporation into an edible composition can begin by determining adesired release profile for an active component (i.e. a first activecomponent). The determination of the desired release profile may be fromknown literature or technical references or by in vitro or in vivotesting. Once the desired release profile is determined, it is typicalto determine the desired tensile strength and/or the desiredhydrophobicity of the encapsulating material used for the polymer matrixthat can release the first active component at the desired release. Oncethe polymer matrix is obtained which can deliver the active component asrequired it is then selected for eventual inclusion in an ediblecomposition.

The method described above may then be repeated for a second activecomponent and for additional active components as described via thedetermination and selection of a suitable polymer matrix.

Other

In some embodiments, the delivery system may be in the form of a powderor granules. The particle size, generally, can vary and not have asignificant effect on the function of the present invention. In oneembodiment, the average particle size is desirably selected according tothe desired rate of release and/or mouthfeel (i.e., grittiness) and thetype of carrier incorporated in the edible composition. Thus, in certainembodiments of the present invention, the average particle size is fromabout 75 to about 600 microns, including 100, 110, 140, 170, 200, 230,260, 290, 320, 350, 370 and all values and ranges there between. As thevalues are an average, one will appreciate within a given sample ofpowder or granules, there may be particles with sizes greater and/orless than the numerical values provided. In one embodiment of theinvention, where the delivery system is incorporated into a chewing gum,the particle size can be less than 600 microns.

The at least one active component incorporated into the delivery systemmanufactured according to the processes described herein include, forexample, a sweetener, such as a high-intensity sweetener, an acid, e.g.,a food grade acid, a flavorant, a pharmaceutical, a therapeutic agent, avitamin, a mineral, a breath freshener, a tooth whitener or cleaner, acooling agent, a warming agent, a sensate, throat-soothing agents,spices, caffeine, drugs, etc. Combinations of these active componentscan be included in the same or different delivery systems. Suchcomponents may be used in amounts sufficient to achieve their intendedeffects.

A variety of well known cooling agents may be employed. For example,among the useful cooling agents are included menthol, xylitol, menthane,menthone, ketals, menthone ketals, menthone glycerol ketals, substitutedp-menthanes, acyclic carboxamides, substituted cyclohexanamides,substituted cyclohaxane carboxamides, substituted ureas andsulfonamides, substituted menthanols, hydroxymethyl and hydroxymethylderivatives of p-menthane, 2-mercapto-cyclo-decanone,2-isopropanyl-5-methylcyclohexanol, hydroxycarboxylic acids with 2-6carbon atoms, cyclohexanamides, menthyl acetate, menthyl lactate,menthyl salicylate, N,N 2,3-trimethyl-2-isopropyl butanamide (WS-23),N-ethyl-p-menthane-3-carboxamide (WS-3), menthyl succinate,3,1-menthoxypropane 1,2-diol, among others. These and other suitablecooling agents are further described in the following U.S. patents, allof which are incorporated in their entirety by reference hereto: U.S.Pat. Nos. 4,230,688; 4,032,661; 4,459,425; 4,136,163; 5,266,592;6,627,233.

Examples of food grade acids which can be used include acetic acid,adipic acid, ascorbic acid, butyric acid, citric acid, formic acid,fumaric acid, glyconic acid, lactic acid, phosphoric acid, malic acid,oxalic acid, succinic acid, tartaric acid and others. Combinations offood grade acids may also be used.

Warming components may be selected from a wide variety of compoundsknown to provide the sensory signal of warming to the user. Thesecompounds offer the perceived sensation of warmth, particularly in theoral cavity, and often enhance the perception of flavors, sweeteners andother organoleptic components. Among the useful warming compoundsincluded are vanillyl alcohol n-butylether (TK-1000) supplied byTakasago Perfumary Company Limited, Tokyo, Japan, vanillyl alcoholn-propylether, vanillyl alcohol isopropylether, vanillyl alcoholisobutylether, vanillyl alcohol n-aminoether, vanillyl alcoholisoamylether, vanillyl alcohol n-hexylether, vanillyl alcoholmethylether, vanillyl alcohol ethylether, gingerol, shogaol, paradol,zingerone, capsaicin, dihydrocapsaicin, nordihydrocapsaicin,homocapsaicin, homodihydrocapsaicin, ethanol, isopropyl alcohol,iso-amylalcohol, benzyl alcohol, glycerine, and combinations thereof.

The sensation of warming or cooling effects may be prolonged with theuse of a hydrophobic sweetener as described in U.S. Patent ApplicationPublication 2003/0072842 A1 which is incorporated in its entirety hereinby reference. For example, such hydrophobic sweeteners include those ofthe formulae I-XI referenced therein. Perillartine may also be added asdescribed in U.S. Pat. No.6,159,509 also incorporated in its entiretyherein by reference.

The breath freshening agents may include in addition to the flavors andcooling agents described hereinabove, a variety of compositions withodor controlling properties. These may include, without limitation,cyclodextrin and magnolia bark extract. The breath freshening agents mayfurther be encapsulated to provide a prolonged breath freshening effect.Examples of malodor-controlling compositions are included in U.S. Pat.No. 5,300,305 to Stapler et al. and in U.S. Patent ApplicationPublication Nos. 2003/0215417 and 2004/0081713 which are incorporated intheir entirety herein by reference.

As described above, a variety of oral care products may also be includedin some embodiments of chewing gums. These may include tooth whiteners,stain removers and anticalculus agents. Examples of these include, butare not limited to hydrolytic agents including proteolytic enzymes,abrasives such as hydrated silica, calcium carbonate, sodium bicarbonateand alumina, other active stain-removing components such assurface-active agents, such as anionic surfactants such as sodiumstearate, sodium palminate, sulfated butyl oleate, sodium oleate, saltsof fumaric acid, glycerol, hydroxylated lecithin, sodium lauryl sulfateand chelators such as polyphosphates, which are typically employed indentifrice compositions as tartar control ingredients. Also included aretetrasodium pyrophosphate and sodium tripolyphosphate, xylitol,hexametaphosphate, and an abrasive silica. Further examples are includedin the following U.S. Patents which are incorporated in their entiretyherein by reference: U.S. Pat. Nos. 5,227,154, 5,378,131 and 6,685,916.

A variety of drugs, including medications, herbs, and nutritionalsupplements may also be included in the gum formulations. Examples ofuseful drugs include ACE-inhibitors, antianginal drugs,anti-arrhythmias, anti-asthmatics, anti-cholesterolemics, analgesics,anesthetics, anti-convulsants, anti-depressants, anti-diabetic agents,anti-diarrhea preparations, antidotes, anti-histamines,anti-hypertensive drugs, anti-inflammatory agents, anti-lipid agents,anti-manics, anti-nauseants, anti-stroke agents, anti-thyroidpreparations, anti-tumor drugs, anti-viral agents, acne drugs,alkaloids, amino acid preparations, anti-tussives, anti-uricemic drugs,anti-viral drugs, anabolic preparations, systemic and non-systemicanti-infective agents, anti-neoplastics, anti-parkinsonian agents,anti-rheumatic agents, appetite stimulants, biological responsemodifiers, blood modifiers, bone metabolism regulators, cardiovascularagents, central nervous system stimulates, cholinesterase inhibitors,contraceptives, decongestants, dietary supplements, dopamine receptoragonists, endometriosis management agents, enzymes, erectile dysfunctiontherapies such as sildenafil citrate, which is currently marketed asViagra®, fertility agents, gastrointestinal agents, homeopathicremedies, hormones, hypercalcemia and hypocalcemia management agents,immunomodulators, immunosuppressives, migraine preparations, motionsickness treatments, muscle relaxants, obesity management agents,osteoporosis preparations, oxytocins, parasympatholytics,parasympathomimetics, prostaglandins, psychotherapeutic agents,respiratory agents, sedatives, smoking cessation aids such asbromocryptine or nicotine, sympatholytics, tremor preparations, urinarytract agents, vasodilators, laxatives, antacids, ion exchange resins,anti-pyretics, appetite suppressants, expectorants, anti-anxiety agents,anti-ulcer agents, anti-inflammatory substances, coronary dilators,cerebral dilators, peripheral vasodilators, psycho-tropics, stimulants,anti-hypertensive drugs, vasoconstrictors, migraine treatments,antibiotics, tranquilizers, anti-psychotics, anti-tumor drugs,anti-coagulants, anti-thrombotic drugs, hypnotics, anti-emetics,anti-nauseants, anti-convulsants, neuromuscular drugs, hyper- andhypo-glycemic agents, thyroid and anti-thyroid preparations, diuretics,anti-spasmodics, terine relaxants, anti-obesity drugs, erythropoieticdrugs, anti-asthmatics, cough suppressants, mucolytics, DNA and geneticmodifying drugs, and combinations thereof.

Examples of other active ingredients include antacids, H2-antagonists,and analgesics. For example, antacid dosages can be prepared using theingredients calcium carbonate alone or in combination with magnesiumhydroxide, and/or aluminum hydroxide. Moreover, antacids can be used incombination with H2-antagonists. Active antacid ingredients include, butare not limited to, aluminum hydroxide, dihydroxyaluminum aminoacetate,aminoacetic acid, aluminum phosphate, dihydroxyaluminum sodiumcarbonate, bicarbonate, bismuth aluminate, bismuth carbonate, bismuthsubcarbonate, bismuth subgallate, bismuth subnitrate, bismuthsubsilysilate, calcium carbonate, calcium phosphate, citrate ion (acidor salt), amino acetic acid, hydrate magnesium aluminate sulfate,magaldrate, magnesium aluminosilicate, magnesium carbonate, magnesiumglycinate, magnesium hydroxide, magnesium oxide, magnesium trisilicate,milk solids, aluminum mono-ordibasic calcium phosphate, tricalciumphosphate, potassium bicarbonate, sodium tartrate, sodium bicarbonate,magnesium aluminosilicates, tartaric acids and salts.

Analgesics include opiates and opiate derivatives, such as OXYCONTIN®,ibuprofen, aspirin, acetaminophen, and combinations thereof that mayoptionally include caffeine.

Other drug ingredients for use in embodiments include anti-diarrhealssuch as inimodium AD, anti-histamines, anti-tussives, decongestants,vitamins, and breath fresheners. Also contemplated for use herein areanxiolytics such as XANAX®; anti-psychotics such as clozaril and Haldol;non-steroidal anti-inflammatories (NSAID's) such as ibuprofen, naproxensodium, VOLTAREN® and LODINE®, anti-histamines such as CLARITIN®,HISMANAL®, RELAFEN®, and TAVIST®D; anti-emetics such as KYTRIL® andCESAMET®; bronchodilators such as BENTOLIN®, PROVENTIL®;anti-depressants such as PROZAC®, ZOLOFT®, and PAXIL®; anti-migrainessuch as IMIGRA®, ACE-inhibitors such as Vasotec, Capoten and Zestril;anti-Alzheimer's agents, such as Nicergoline; and CaH-antagonists suchas PROCARDIA®, ADALAT®, and Calan.

H2-antagonists which can be used include cimetidine, ranitidinehydrochloride, famotidine, nizatidien, ebrotidine, mifentidine,roxatidine, pisatidine and aceroxatidine

A variety of other nutritional supplements may also be included, such asvitamin or mineral as mentioned above. For example, vitamin A, vitaminC, vitamin D, vitamin E, vitamin K, vitamin B6, vitamin B12, thiamine,riboflavin, biotin, folic acid, niacin, pantothenic acid, sodium,potassium, calcium, magnesium, phosphorus, sulfur, chlorine, iron,copper, iodine, zinc, selenium, manganese, choline, chromium,molybdenum, fluorine, cobalt and combinations thereof, may be used.

Examples of nutritional supplements are set forth in U.S. PatentApplication Publication Nos. 2003/0157213 A1, 2003/0206993 and2003/0099741 A1 which are incorporated in their entirety herein byreference.

Various herbs may also be included such as those with various medicinalor dietary supplement properties. Herbs are generally aromatic plants orplant parts that can be used medicinally or for flavoring. Suitableherbs can be used singly or in various mixtures. Examples includeEchinacea, Goldenseal, Calendula, Aloe, Blood Root, Grapefruit SeedExtract, Black Cohosh, Cranberry, Ginko Biloba, St. John's Wort, EveningPrimrose Oil, Yohimbe Bark, Green Tea, Maca, Bilberry, Lutein, andcombinations thereof.

Flavorants which may be used include those flavors known to the skilledartisan, such as natural and artificial flavors. These flavorings may bechosen from synthetic flavor oils and flavoring aromatics and/or oils,oleoresins and extracts derived from plants, leaves, flowers, fruits,and so forth, and combinations thereof. Nonlimiting representativeflavor oils include spearnint oil, cinnamon oil, oil of wintergreen(methyl salicylate), peppermint oil, clove oil, bay oil, anise oil,eucalyptus oil, thyme oil, cedar leaf oil, oil of nutmeg, allspice, oilof sage, mace, oil of bitter almonds, and cassia oil. Also usefulflavorings are artificial, natural and synthetic fruit flavors such asvanilla, and citrus oils including lemon, orange, lime, grapefruit, andfruit essences including apple, pear, peach, grape, blueberry,strawberry, raspberry, cherry, plum, pineapple, apricot and so forth.These flavoring agents may be used in liquid or solid form and may beused individually or in admixture. Commonly used flavors include mintssuch as peppermint, menthol, spearmint, artificial vanilla, cinnamonderivatives, and various fruit flavors, whether employed individually orin admixture. Flavors may also provide breath freshening properties,particularly the mint flavors when used in combination with the coolingagents, described herein below.

Other useful flavorings include aldehydes and esters such as cinnamylacetate, cinnamaldehyde, citral diethylacetal, dihydrocarvyl acetate,eugenyl formate, p-methylamisol, and so forth may be used. Generally anyflavoring or food additive such as those described in Chemicals Used inFood Processing, publication 1274, pages 63-258, by the National Academyof Sciences, may be used. This publication is incorporated herein byreference. This may include natural as well as synthetic flavors.

Further examples of aldehyde flavorings include but are not limited toacetaldehyde (apple), benzaldehyde (cherry, almond), anisic aldehyde(licorice, anise), cinnamic aldehyde (cinnamon), citral, i.e.,alpha-citral (lemon, lime), neral, i.e., beta-citral (lemon, lime),decanal (orange, lemon), ethyl vanillin (vanilla, cream), heliotrope,i.e., piperonal (vanilla, cream), vanillin (vanilla, cream), alpha-amylcinnamaldehyde (spicy fruity flavors), butyraldehyde (butter, cheese),valeraldehyde (butter, cheese), citronellal (modifies, many types),decanal (citrus fruits), aldehyde C-8 (citrus fruits), aldehyde C-9(citrus fruits), aldehyde C-12 (citrus fruits), 2-ethyl butyraldehyde(berry fruits), hexenal, i.e., trans-2 (berry fruits), tolyl aldehyde(cherry, almond), veratraldehyde (vanilla), 2,6-dimethyl-5-heptenal,i.e., melonal (melon), 2,6-dimethyloctanal (green fruit), and2-dodecenal (citrus, mandarin), cherry, grape, blueberry, blackberry,strawberry shortcake, and mixtures thereof.

The sweeteners used may be selected from a wide range of materialsincluding water-soluble sweeteners, water-soluble artificial sweeteners,water-soluble sweeteners derived from naturally occurring water-solublesweeteners, dipeptide based sweeteners, and protein based sweeteners,including mixtures thereof. Without being limited to particularsweeteners, representative categories and examples include:

(a) water-soluble sweetening agents such as dihydrochalcones, monellin,steviosides, glycyrrhizin, dihydroflavenol, and sugar alcohols such assorbitol, mannitol, maltitol, and L-aminodicarboxylic acid aminoalkenoicacid ester amides, such as those disclosed in U.S. Pat. No. 4,619,834,which disclosure is incorporated herein by reference, and mixturesthereof;

(b) water-soluble artificial sweeteners such as soluble saccharin

salts, i.e., sodium or calcium saccharin salts, cyclamate salts,acesulfame salts, such as the sodium, ammonium or calcium salt of3,4-dihydro-6-methyl-1,2,3-oxathiazine-4-one-2,2-dioxide, the potassiumsalt of 3,4-dihydro-6-methyl-1,2,3-oxathiazine-4-one-2,2-dioxide(Acesulfame-K), the free acid form of saccharin, and mixtures thereof,

(c) dipeptide based sweeteners, such as L-aspartic acid derivedsweeteners, such as L-aspartyl-L-phenylalanine methyl ester (Aspartame)and materials described in U.S. Pat. No. 3,492,131,L-alphaaspartyl-N-(2,2,4,4-tetramethyl-3-thietanyl)-D-alaninamidehydrate (Alitame), methyl esters of L-aspartyl-L-phenylglycerine andL-aspartyl-L-2,5-dihydrophenyl-glycine,L-aspartyl-2,5-dihydro-L-phenylalanine;L-aspartyl-L-(1-cyclohexen)-alanine, neotame, and mixtures thereof;

(d) water-soluble sweeteners derived from naturally occurringwater-soluble sweeteners, such as stevosides, chlorinated derivatives ofordinary sugar (sucrose), e.g., chlorodeoxysugar derivatives such asderivatives of chlorodeoxysucrose or chlorodeoxygalactosucrose, known,for example, under the product designation of Sucralose; examples ofchlorodeoxysucrose and chlorodeoxygalactosucrose derivatives include butare not limited to: 1-chloro-1′-deoxysucrose;4-chloro-4-deoxy-alpha-D-galactopyranosyl-alpha-D-fructofuranoside, or4-chloro-4-deoxygalactosucrose;4-chloro-4-deoxy-alpha-D-galactopyranosyl-1-chloro-1-deoxy-beta-D-fructo-furanoside,or 4,1′-dichloro-4,1′-dideoxygalactosucrose; 1′,6′-dichloro1′,6′-dideoxysucrose;4-chloro-4-deoxy-alpha-D-galactopyranosyl-1,6-dichloro-1,6-dideoxy-beta-D-fructofuranoside, or 4,1′,6′-trichloro-4,1′,6′-trideoxygalactosucrose;4,6-dichloro-4,6-dideoxy-alpha-D-galactopyranosyl-6-chloro-6-deoxy-beta-D-fructofuranoside,or 4,6,6′-trichloro-4,6,6′-trideoxygalactosucrose;6,1′,6′-trichloro-6,1′,6′-trideoxysucrose;4,6-dichloro-4,6-dideoxy-alpha-D-galacto-pyranosyl-1,6-dichloro-1,6-dideoxy-beta-D-fructofuranoside, or

4,6,1′,6′-tetrachloro 4,6,1′,6′-tetradeoxygalacto-sucrose; and4,6,1′,6′-tetradeoxy-sucrose, and mixtures thereof,

(e) protein based sweeteners such as thaumaoccous danielli (Thaumatin Iand II), talin, and (f) amino acid based sweeteners.

The intense sweetening agents may be used in many distinct physicalforms well-known in the art to provide an initial burst of sweetnessand/or a prolonged sensation of sweetness. Without being limitedthereto, such physical forms include free forms, such as spray dried,powdered, beaded forms, encapsulated forms, and mixtures thereof. In oneembodiment, the sweetener is a high intensity sweetener such asaspartame, sucralose, and acesulfame potassium (Ace-K).

The active component (e.g., sweetener), which is part of the deliverysystem, may be used in amounts necessary to impart the desired effectassociated with use of the active component (e.g., sweetness). Withrespect to their presence in the delivery system, the active componentsmay be present in amounts of from about 1% to 70% by weight based on thetotal weight of the delivery system, including 5, 10, 15, 20, 25, 30,35, 40, 45, 50, 55, 60, 65% by weight, and all values and ranges therebetween, for example, from about 10% to 40% by weight based on the totalweight of the delivery system. For typical edible compositions includingchewing gum compositions, confectionery compositions and beveragecompositions, the sweeteners may be present in amounts of from about0.1% to 6% by weight based on the total weight of the ediblecomposition, including 0.5, 1, 2, 3, 4, 5% by weight and all values andsubranges there between, for example, 0.5% to 3% by weight. The activecomponent especially when the active component is a sweetener may alsobe present in the edible composition in free form depending on therelease profile desired.

In another aspect of the present invention, there is provided ediblecompositions which comprise the present delivery system and a carrier inan amount appropriate to accommodate the delivery system. The term“carrier” as used herein refers to an orally acceptable vehicle such asthe soluble and insoluble components of a chewing gum compositioncapable of being mixed with the delivery system, and which will notcause harm to warm-blooded animals including humans. The carriersfurther include those components of the composition that are capable ofbeing commingled without significant interaction with the deliverysystem.

In one embodiment of the present invention, the edible composition is achewing gum composition having prolonged release (e.g., typically atleast 15 minutes) of the active component. The chewing gum compositioncomprises a chewing gum base and the delivery system of the presentinvention that comprises an encapsulating material and at least oneencapsulated active component such as, for example, a sweetener or aflavorant. The delivery system is present in amounts from about 0.2% to10% by weight based on the total weight of the chewing gum composition,including 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0% by weightincluding all values and subranges there between, for example, fromabout 1% to 5% by weight.

The present invention may be incorporated with a variety of processesfor preparing chewing gum compositions as known in the art. Such chewinggum compositions may be and include a variety of different formulationsthat are typically used to make chewing gum products. Typically, achewing gum composition contains a chewable gum base portion, which isessentially free of water and is water insoluble and a water solublebulk portion.

The water soluble portion is generally released from the gum baseportion over a period of time during chewing. The gum base portion isretained in the mouth throughout the chewing. The water insoluble gumbase generally comprises elastomers, elastomer solvents, plasticizers,waxes, emulsifiers, and inorganic fillers. Plastic polymers such aspolyvinyl acetate, which behave somewhat as plasticizers, are alsoincluded. Other plastic polymers that may be used include polyvinyllaurate, crosslinked polyvinyl pyrrolidone and polyhydroxy alkanoates.

The elastomers may constitute from about 5% to 95% by weight of the gumbase. In another embodiment, the elastomers may constitute from about10% to 70% by weight of the gum base and in another embodiment, 15% to45% by weight of the gum base. Examples of elastomers include syntheticelastomers such as polyisobutylene, polybutylene, isobutylene-isopreneco-polymers, styrene-butadiene co-polymers, polyvinyl acetate and thelike. Elastomers may also include natural elastomers such as naturalrubber as well as natural gums such as jelutong, lechi caspi, perillo,massaranduba balata, chicle, gutta hang kang or combinations thereof.Other elastomers are known to those of ordinary skill in the art.

Elastomer plasticizers modify the finished gum finrness when used in thegum base. Elastomer plasticizers are typically present in an amount upto 75% by weight of the gum base. In another embodiment, the elastomerplasticizers are present in an amount of from about 5% to 45% by weightof the gum base and in another embodiment from about 10% to 30% byweight of gum base. Examples of elastomer plasticizers include naturalrosin esters such as glycerol ester of partially hydrogenated rosin,glycerol ester of tall oil rosin, pentaerythritol esters of partiallyhydrogenated rosin, methyl and partially hydrogenated methyl esters ofrosin, and the like. Synthetic elastomer plasticizers such as terpeneresins may also be employed in gum base composition.

Waxes include synthetic and naturally occurring waxes such aspolyethylene, bees wax, camauba and the like. Petroleum waxes such aparaffin may also be used. The waxes may be present in the amount up to30% by weight of the gum base. Waxes aid in the curing of the finishedgum and help improve the release of flavor and may further extend theshelf life of the product.

Elastomer solvents are often resins such as terpene resins.Plasticizers, sometimes referred to as softeners, are typically fats andoils, including tallow, hydrogenated vegetable oils, and cocoa butter.

Gum base typically also includes a filler component. The fillercomponent modifies the texture of the gum base and aid processing.Examples of such fillers include magnesium and aluminum silicates, clay,alumina, talc, titanium oxide, cellulose polymers, and the like. Fillersare typically present in the amount of from 1% to 60% by weight.

Emulsifiers, which sometimes also have plasticizing properties, includeglycerol monostearate, lecithin, and glycerol triacetate. Further, gumbases may also contain optional ingredients such as antioxidants,colors, and flavors.

The insoluble gum base may be present in the amount of from about 5% to95% by weight of the chewing gum. In one embodiment, the insoluble gumbase may present in the amount of from about 10% to 50% by weight of thegum base, and in another embodiment from about 20% to 40% by weight ofthe gum base.

Softeners are added to the chewing gum in order to optimize thechewability and mouth feel of the gum. Softeners, also known in the artas plasticizers or plasticizing agents, is generally present in amountsfrom about 0.5% to 15% by weight based on the total weight of thechewing gum composition. Softeners contemplated by the present inventioninclude, for example, lecithin. Further, aqueous sweetener solutionssuch as those containing sorbitol, hydrogenated starch hydrolysate, cornsyrup, and combinations thereof may be used as softeners and bindingagents in the gum.

The chewing gum compositions of the present invention may be coated oruncoated and be in the form or slabs, sticks, pellets, balls and thelike. The composition of the different forms of the chewing gumcompositions will be similar but may vary with regard to the ratio ofthe ingredients. For example, coated gum compositions may contain alower percentage of softeners. Pellets and balls have a small chewinggum core, which is then coated with either a sugar solution or asugarless solution to create a hard shell. Slabs and sticks are usuallyformulated to be softer in texture than the chewing gum core.

In accordance with one aspect of the chewing gum composition of thepresent invention, the delivery system is added during the manufactureof the chewing gum composition. In another aspect of the presentinvention, the delivery system is added as one of the last steps, forexample, the last step in the formation of the chewing gum composition.

The Inventors have determined that this process modificationincorporates the delivery system into the gum composition withoutmaterially binding the delivery system therein such as may occur if thedelivery system is mixed directly with the gum base. Thus, the deliverysystem, while only loosely contained within the gum composition can moreeffectively release the active component therefrom during a typicalchewing operation. Thus, a material portion of the delivery system isfree of the gum base and the corresponding ingredients of the chewinggum.

Coating techniques for applying a coating for a chewing gum compositionsuch as pan and spray coating are well known. In one embodiment, coatingwith solutions adapted to build a hard candy layer can be employed. Bothsugar and sugar alcohols may be used for this purpose together with highintensity sweeteners, colorants, flavorants and binders.

Other components may be added in minor amounts to the coating syrup andinclude moisture absorbing compounds, anti-adherent compounds,dispersing agents and film forming agents. The moisture absorbingcompounds suitable for use in the coating syrups include mannitol ordicalcium phosphate. Examples of useful anti-adherent compounds, whichmay also function as a filler, include talc, magnesium trisilicate andcalcium carbonate. These ingredients may be employed in amounts of fromabout 0.5% to 5% by weight of the syrup. Examples of dispersing agents,which may be employed in the coating syrup, include titanium dioxide,talc or other anti-adherent compounds as set forth above.

The coating syrup is usually heated and a portion thereof deposited onthe cores. Usually a single deposition of the coating syrup is notsufficient to provide the desired amount or thickness of coating andsecond, third or more coats of the coating syrup may be applied to buildup the weight and thickness of the coating to desired levels with layersallowed to dry in-between coats.

A method of preparing a chewing gum composition is provided bysequentially adding the various chewing gum ingredients including thedelivery system of the present invention to any commercially availablemixer known in the art. After the ingredients have been thoroughlymixed, the gum base is discharged from the mixer and shaped into thedesired form such as by rolling into sheets and cutting into sticks,extruding into chunks, or casing into pellets.

Generally, the ingredients are mixed by first melting the gum base andadding it to the running mixer. The base may also be melted into themixer itself. Colors or emulsifiers may also be added at this time. Asoftener may be added to the mixer at this time, along with syrup and aportion of the bulking agent. Further parts of the bulking agent arethen added to the mixer. Flavorants are typically added with the finalportion of the bulking agent. Finally, the delivery system exhibiting apredetermined tensile strength is added to the resulting mixture. Otheroptional ingredients are added in the batch in a typical fashion, wellknown to those of ordinary skill in the art.

The entire mixing procedure typically takes from five to fifteenminutes, but longer mixing times may be required. Those skilled in theart will recognize that many variations of the above-described proceduremay be follows.

After the ingredients are mixed, the gum mass may be formed into avariety of shapes and products. For example, the ingredients may beformed into pellets or balls and used as cores to make a coated chewinggum product. However, any type of chewing gum product can be utilizedwith the present invention.

If a coated product is desired, the coating may contain ingredients suchas flavorants, artificial sweeteners, dispersing agents, coloringagents, film formers and binding agents. Flavorants contemplated by thepresent invention, include those commonly known in the art such asessential oils, synthetic flavors, or mixtures thereof, including butare not limited to, oils derived from plants and fruits such as citrusoils, fruit essences, peppermint oil, spearmint oil, other mint oils,clove oil, oil of wintergreen, anise and the like. The flavorants mayalso be added to the coating syrup in an amount such that the coatingmay be present in amounts of from about 0.2% to 1.2% by weight flavoringagent. In another embodiment, the coating may be present in amounts fromabout 0.7% to 1.0% by weight flavoring agent.

Dispersing agents are often added to syrup coatings for the purpose ofwhitening and tack reduction. Dispersing agents contemplated by thepresent invention to be employed in the coating syrup include titaniumdioxide, talc, or any other anti-stick compound. The dispersing agentmay be added to the coating syrup in an amount such that the coatingcontains from about 0.1% to 1.0%, including 0.2, 0.3, 0.4, 0.5, 0.6,0.7, 0.8, 0.9 and all values and ranges there between, for example, fromabout 0.3% to 0.6% by weight of the agent.

Coloring agents may be added directly to the coating syrup in dye orlake form. Coloring agents contemplated by the present invention includefood quality dyes. Film formers may be added to the coating syrupinclude methylcellulose, carboxymethyl cellulose, ethyl cellulose,hydroxyethyl cellulose, and the like or combinations thereof. Bindingagents may be added either as an initial coating on the chewing gumcenter or may be added directly to the coating syrup. Binding agentscontemplated by the present invention include gum arabic, gum talha,gelatin, vegetable gums, and the like. The binding agents, when added tothe coating syrup, are typically added in amounts from about 0.5% to 10%by weight.

The present invention further encompasses confectionery compositionscontaining the delivery system of the present invention. Confectionerycompositions include, for example, compressed tablets such as mints,hard boiled candies, chocolates, chocolate containing products, nutrientbars, nougats, gels, centerfill confections, fondants, panning goods,consumable thin films and other compositions falling within thegenerally accepted definition of confectionery compositions.

Confectionery compositions in the form of pressed tablets such as mintsmay generally be made by combining finely sifted sugar or sugarsubstitute, flavoring agent (e.g. peppermint flavor) bulking agent suchas gum arabic, and an optional coloring agent. The flavoring agent,bulking agent are combined and then gradually the sugar or sugarsubstitute are added along with a coloring agent if needed.

The product is then granulated by passing through a seize of desiredmesh size (e.g. 12 mesh) and then dried typically at temperatures offrom about 55° C. to 60° C. The resulting powder is fed into a tabletingmachine fitted with a large size punch and the resulting pellets arebroken into granules and then pressed.

High boiled candies typically contain sugar or sugar substitute,glucose, water, flavoring agent and optional coloring agent. The sugaris dissolved in the water and glucose is then added. The mixture isbrought to a boil. The resulting liquid to which may previously havebeen added a coloring agent is poured onto an oiled slab and cooled. Theflavoring agent are then added and kneaded into the cooled mass. Theresulting mixture is then fed to a drop roller assembly known in the artto form the final hard candy shape.

A nougat composition typically includes two principal components, a highboiled candy and a frappe. By way of example, egg albumen or substitutethereof is combined with water and whisked to form a light foam. Sugarand glucose are added to water and boiled typically at temperatures offrom about 130° C. to 140° C. and the resulting boiled product is pouredinto a mixing machine and beat until creamy.

The beaten albumen and flavoring agent are combined with the creamyproduct and the combination is thereafter thoroughly mixed.

Further details regarding the preparation of confectionery compositionscan be found in Skuse's Complete Confectioner (13^(th) Edition) (1957)including pp. 41-71, 133-144, and 255-262; and Sugar ConfectioneryManufacture (2^(nd) Edition) (1995), E. B. Jackson, Editor, pp.129-168,169-188, 189-216, 218-234, and 236-258 each of which is incorporatedherein by reference.

Except as otherwise noted, the amount of the ingredients incorporatedinto the compositions according to the present invention is designatedas % by weight based on the total weight of the composition.

EXAMPLES Example 1 Compressed Tablet Encapsulation Method

The following experiments demonstrate the advantages of forming tabletsusing compression and low temperature fusion for relatively heatsensitive active ingredients.

Sucralose was mixed with powdered polyvinyl acetate and 5% fat andextruded at 110° C. Extensive degradation of the sucralose was observed.In an alternative encapsulation, sucralose was mixed with powderedpolyvinyl acetate, 2% polyvinylpyrollidone and 1% magnesium stearate andpressed into tablets at 25° C. The tablets were then heated to 80° C.,which softened the polymer and fused the polyvinylacetate with thesucralose. No discloration was observed. Thereafter, the tablets werecooled, ground and sized and analyzed. No decomposition of thesucroloase was observed.

Example 2 Spray Coating of Sucralose Using Gum Arabic (Sucralose=50%)

Ingredient Percent Center Cores Sucralose 50.0 CelluloseMicrocrystalline 15.0 Dicalciumphosphate 12.0 Coating Solution PurifiedWater Gum Arabic 23.0 Total 100.0

A Wurster process is used to encapsulate Sucralose. Coating solution isprepared using 20% gum Arabic solution in water by stirring at 35 C for2 hrs. Sucralose/Cellulose and dicalciumphosphate are suspended in afluidizing air stream which provide generally cyclic flow in front of aspray nozzle. The spray nozzle sprays an atomized flow of coatingsolution for 115 minutes. The coated particles are then dried in thefluidized chamber for 50 minutes and stored below 35° C. under dryconditions.

Example 3 Encapsulation of Coated Sucralose/Gum Arabic UsingPolyvinylacetate

Composition: Ingredient Percent Polyvinyl Acetate 57.00% HydrogenatedOil 3.00% Coated Sucralose/gum arabic (from example 2) 40.00% Total100.00%

Polyvinylacetate is melted at a temperature of about 85° C. in a highshear mixer such as extruder (single or twin screw) or sigma or Banburymixer. The hydrogenated oil is added to the molten polyvinylacetate. Gumarabic coated sucralose is then added to the resulting mixture and mixedunder high shear to completely disperse the ingredients. The resultingfiled polymer met is cooled and ground to particle size of less than 590microns. The encapsulated sucralose matrix is stored in air tightcontainers with low humidity below 35° C.

Example 4 Chewing Gum Composition Containing Free Sucralose

Ingredient Percent Gum Base 36.0 Sorbitol 60.1 Glycerin 1.0 Flavor Blend2.5 Sucralose (Free) 0.4 Total 100.0

Chewing gum is prepared in the following manner: The gum base is meltedin a mixer. The remaining ingredients are added to the molten gum base.The melted gum base with ingredients are mixed to completely dispersethe ingredients. The resulting chewing gum is allowed to cool. Thecooled chewing gum is sized and conditioned for about a week andpackaged.

Example 5 Chewing Gum Composition Containing Encapsulated Sucralose(from Example 3 with 20% Sucralose)

Composition: Ingredient Percent Gum Base 36.0 Sorbitol 58.5 Glycerin 1.0Flavor Blend 2.5 Encapsulated coated 2.0 sucralose (from example 3)Total 100.0

Chewing gum is prepared in the following manner: The gum base is meltedin a mixer. The remaining ingredients are added to the molten gum base.The melted gum base with ingredients are mixed to completely dispersethe ingredients. The resulting chewing gum is allowed to cool. Thecooled chewing gum is sized and conditioned for about a week andpackaged.

Example 6 Spray Coating of WS-23

Composition: Ingredient Percent Center Cores WS-23 50.0 CelluloseMicrocrystalline 15.0 Dicalciumphosphate 12.0 Coating Solution PurifiedWater Gum Arabic 23.0 100.0

Wurster process is used to encapsulate WS-23. Coating solution isprepared using 20% gum arabic solution in water by stirring at 35° C.for 2 hrs. WS-23/Cellulose and dicalciumphosphate are suspended in afluidizing air stream which provide generally cyclic flow in front of aspray nozzle. The spray nozzle sprays an atomized flow of coatingsolution for 115 minutes. The coated particles are then dried in thefluidized chamber for 50 minutes and stored below 35° C. under dryconditions.

Example 7 Encapsulation of Coated WS-23

Composition: Ingredient Percent Polyvinyl Acetate 57.00% HydrogenatedOil 3.00% coated WS-23/gum Arabic 40.00% (from example 6) Total 100.00%

Polyvinylacetate is melted at a temperature of about 85° C. in a highshear mixer such as an extruder (single or twin screw) or sigma orBanbury mixer. The hydrogenated oil is added to the moltenpolyvinylacetate. Gum arabic coated WS-23 is then added to the resultingmixture and mixed under high shear to completely disperse theingredients. The resulting filled polymer melt is cooled and ground toparticles size of less than 590 microns. The encapsulated sucralosematrix is stored in air tight containers with low humidity below 35° C.

Example 8 Chewing Gum Composition Containing Free Aspartame, AceK,Sucralose and Encapsulated Sucralose (from Example 3 with 20% Sucralose)

Composition: Ingredient Percent Gum Base 36.0000 Sorbitol 57.9000Glycerin 1.0000 Flavor Blend 2.5000 Aspartame (free) 0.4000 AceK (free)0.1200 Sucralose (free) 0.0500 Encapsulated coated 2.0000 sucralose(from example 3) Total 100.0

Chewing gum is prepared in the following manner: The gum base is meltedin a mixer. The remaining ingredients are added to the molten gum base.The melted gum base with ingredients are mixed to completely dispersethe ingredients. The resulting chewing gum is allowed to cool. Thecooled chewing gum is sized and conditioned for about a week andpackaged.

Example 9 Gum Chew-Out Release Analysis

Gums prepared in Examples 4 and 5 were chewed by a panel and bolus werecollected at 0, 5, 10, 15, and 20 minutes. Residual sucralose wasanalyzed in each chewed-bolus. Average residual sucralose versus chewtime is tabulated below and shown in FIG. 1.

Time 0 5 10 15 20 Example 4 % retained 100 32.2 16.6 6.8 3.0 Example 5 %retained 100 57.0 41.8 27.5 14.0

Obviously, numerous modifications and variations of the presentinvention are possible in light of the above teachings. It is thereforeto be understood that within the scope of the appended claims, theinvention may be practiced otherwise than as specifically describedherein.

The invention claimed is:
 1. A delivery system having a preselecteddesired release profile of at least one active component and suitablefor incorporation into an edible composition comprising at least oneactive component fully coated with at least one coating material, andsaid coated active component further fully coated with at least oneencapsulating material and least one tensile strength modifying agent toform said delivery system; wherein the at least one coating material isselected from the group consisting of gum Arabic, cellulose, modifiedcellulose, gelatin, polyol, cyclodextrin, zein, polyvinyl alcohol, andmixtures thereof, wherein the coating material is less miscible with theencapsulating material relative to the miscibility of the activecomponent with the encapsulating material, and, wherein the coatingmaterial provides a coating thickness of from about 1 micron to about200 microns between the at least one active component and theencapsulating material; wherein the at least one encapsulating materialis a polymer which is selected from the group consisting of polyvinylacetate, crosslinked polyvinyl pyrrolidone, polylactic acid,polyhydroxyalkanoates, and combinations thereof and wherein theencapsulating material is present in an amount of from about 30% to 99%by weight based on the total weight of the delivery system; wherein theat least one tensile strength modifying agent is selected from the groupconsisting of hydrogenated vegetable oil, talc, dicalcium phosphate,calcium carbonate, and combinations thereof and wherein the tensilestrength modifying agent is present in an amount of from about 1% to 40%by weight based on the total weight of the delivery system; wherein thedelivery system provides a desired release profile of the at least oneactive component by the combination of (1) adding a preselected amountof at least one tensile strength modifying agent in a range from 1% to40% by weight of the total weight of the delivery system and (2)employing an encapsulating material having a preselected hydrophobicityhaving a water absorption from about 5% to about 50% as measured inaccordance to ASTM D570-98 thereby obtaining an overall tensile strengthof the delivery system that corresponds to the preselected desiredrelease profile of the at least one active component, and wherein thedelivery system has a tensile strength of at least 10,000 psi.
 2. Thedelivery system of claim 1, wherein the coating material is not misciblewith the encapsulating material.
 3. The delivery system of claim 1,wherein the tensile strength of the delivery system is at least 20,000psi.
 4. The delivery system of claim 1, wherein the at least one activecomponent is present in an amount of from about 10% to 40% by weightbased on the total weight of the delivery system.
 5. The delivery systemof claim 1, wherein the encapsulating material is present in an amountof from about 60% to 90% by weight based on the total weight of thedelivery system.
 6. The delivery system of claim 1, wherein the tensilestrength modifying agent is at least one hydrogenated vegetable oil andis present in an amount of from about 1% to 5% by weight based on thetotal weight of the delivery system.
 7. The delivery system of claim 1,wherein the active component is selected from the group consisting of asweetener, an acid, a flavorant, a pharmaceutical, a therapeutic agent,a vitamin, a breath freshener, a cooling agent and combinations thereof.8. The delivery system of claim 7, wherein the active component is atleast one sweetener and is a high intensity sweetener.
 9. The deliverysystem of claim 7, wherein the active component is a sweetener selectedfrom the group consisting of an amino acid based sweetener, a dipeptidesweetener, glycyrrhizin, saccharin, a saccharin salt, an acesulfamesalt, a cyclamate, a stevioside, talin, a dihydrochalone compound, achlorinated sucrose, and combinations thereof.
 10. The delivery systemof claim 7, wherein the active component is a sweetener selected fromthe group consisting of neotame, aspartame, sucralose, acesulfamepotassium, and a mixture thereof.
 11. The delivery system of claim 1,wherein the delivery system has an average particle size of about 75 toabout 900 microns.
 12. An edible composition comprising at least onedelivery system as claimed in claim
 1. 13. The edible composition ofclaim 12, which is selected from the group consisting of a food product,a pharmaceutical composition, a foodstuff, a nutrient- containingcomposition, a vitamin, a nutraceutical, and a combination thereof. 14.The edible composition of claim 11, which is a confectionary.
 15. Theedible composition of claim 11, which is a chewing gum composition,wherein the at least one delivery system is present from about 0.2% toabout 10% by weight based on the total weight of the chewing gumcomposition.
 16. A method of manufacturing the edible composition ofclaim 11, comprising mixing the delivery system with at least oneingredient of the edible composition.
 17. A method of preparing at leastone delivery system which comprise at least one active component, atleast one encapsulating material and at least one tensile strengthmodifying agent, said delivery system having a preselected releaseprofile of at least one active component and suitable for incorporationinto an edible composition, the method comprising: selecting a coatingmaterial that is less miscible with the encapsulating material relativeto the miscibility of the at least one active component with the atleast one encapsulating material; wherein the at least one coatingmaterial is selected from the group consisting of gum Arabic, cellulose,modified cellulose, gelatin, polyol, cyclodextrin, zein, polyvinylalcohol, and mixtures thereof; fully coating the at least one activecomponent with the coating material, wherein the coating materialprovides a coating thickness of from about 1 micron to about 200micronsbetween the at least one active component and the encapsulatingmaterial; mixing the coated active component with the at least oneencapsulating material and with the at least one tensile strengthmodifying agent to form a solid state mixture; wherein the encapsulatingmaterial is a polymer which is selected from the group consisting ofpolyvinyl acetate, crosslinked polyvinyl pyrrolidone, polylactic acid,polyhydroxyalkanoates, and combinations thereof and wherein theencapsulating material is present in an amount of from about 30% to 99%by weight based on the total weight of the delivery system; and whereinthe at least one tensile strength modifying agent is selected from thegroup consisting of hydrogenated vegetable oil, talc, dicalciumphosphate, calcium carbonate, and combinations thereof and wherein thetensile strength modifying agent is present in an amount of from about1% to 40% by weight based on the total weight of the delivery system;and wherein the delivery system has a tensile strength of at least10,000 psi, and grinding the solid state mixture to an average particlesize of about 75 microns to about 900 microns to form the deliverysystem; and providing a desired release profile of the at least oneactive component by the combination of (1) adding a preselected amountof at least one tensile strength modifying agent in the range from 1% to40% by weight of the total weight of the delivery system and (2)employing an encapsulating material having a preselected hydrophobicityhaving a water absorption from about 5% to about 50% as measured inaccordance with ASTM D570-98 thereby obtaining an overall tensilestrength of the delivery system that corresponds to the preselecteddesired release profile of the at least one active component.
 18. Adelivery system having a preselected release profile of at least oneactive component and suitable for incorporation into chewing gumcomposition comprising at least one active component fully coated withat least one coating material, and said coated active component furtherfully coated with at least one encapsulating material and least onetensile strength modifying agent to form said delivery system; whereinthe at least one coating material is selected from the group consistingof gum Arabic, cellulose, modified cellulose, gelatin, polyol,cyclodextrin, zein, polyvinyl alcohol, and mixtures thereof, wherein thecoating material is less miscible with the encapsulating materialrelative to the miscibility of the active component with theencapsulating material, and, wherein the coating material provides acoating thickness of from about 10 micron to about 50 microns betweenthe at least one active component and the encapsulating material;wherein the at least one encapsulating material is polyvinyl acetate,and wherein the encapsulating material is present in an amount of fromabout 60% to 90% by weight based on the total weight of the deliverysystem; wherein the at least one tensile strength modifying agent is oneor more hydrogenated vegetable oils, and wherein the tensile strengthmodifying agent is present in an amount of from about 1% to 5% by weightbased on the total weight of the delivery system; wherein the deliverysystem provides a desired release profile of the at least one activecomponent by the combination of (1) adding a preselected amount of atleast one tensile strength modifying agent in a range from 1% to 5% byweight of the total weight of the delivery system and (2) employing anencapsulating material having a preselected hydrophobicity therebyobtaining an overall tensile strength of the delivery system having awater absorption in the range from about 5% to about 50% as measuredaccording to ASTM D570-98 that corresponds to the preselected desiredrelease profile of the at least one active component, and wherein thedelivery system has a tensile strength of at least 10,000 psi.
 19. Thedelivery system of claim 18, wherein the delivery system has an averageparticle size of about 75 to about 900 microns.